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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EK9788 / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy pharynx, Blood creatine phosphokinase, Blood creatinine, Blood lactate dehydrogenase, Blood lactic acid, Blood pressure systolic, Body temperature, C-reactive protein, Depressed mood, Oxygen saturation, Respiratory rate, Sepsis, Skeletal survey, White blood cell count, General physical health deterioration, Computerised tomogram head, Troponin, Blood pressure measurement
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
Write-up: SEPSIS; Reduced condition in the period before admission/ general condition reduced; Depressed mood in the period before admission; This is a spontaneous report downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U8n9n, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00017057. A contactable physician reported that an 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY, batch/lot number EK9788), via intramuscular route on 03Feb2021, at single dose for covid-19 immunisation. Medical history included ongoing living in nursing home and ongoing dementia, and pain. Concomitant medications included risperidone (RISPERDAL), and fentanyl (FENTANYL SANDOZ) for pain. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 13Jan2021 for covid-19 immunisation. The patient experienced sepsis (hospitalization, death) on 23Feb2021 with fatal outcome, and reduced condition in the period before admission and depressed mood in the period before admission, both on an unspecified date in Feb2021 with outcome of not recovered. The patient was hospitalized from 23Feb2021. Clinical course: On the 23Feb2021 she was found hanging on the walking aid with systolic BP 70 mm Hg, increased respiration and an O2 saturation of 88 %. Initially suspected as an adverse reaction to opioids (naloxone was administered), but she was on 23Feb2021 at 13:00 PM admitted to hospital where sepsis was suspected. Before admittance general condition reduced, depressed mood during the last couple of weeks. Found hanging on the walking aid. The patient was administered naloxone to suspected overdose analgetics, slight improvement. Qsofa 2/3, treatment with antibiotics started. At 20:30 the patients mostly unchanged. The patient died during the night. The patient underwent lab tests and procedures on 23Feb2021 which included alanine aminotransferase: 400 IU/l, aspartate aminotransferase: 400 IU/l, Biopsy nasopharynx: negative, Creatine kinase: 5000 IU/l, blood creatinine: 124 umol/l, blood lactate dehydrogenase: 1000 IU/l, blood lactic acid: 7.1 mmol/l, blood lactic acid: 3.3 mmol/l, blood pressure measurement: 108/72 mmHg, blood pressure systolic: 70 mmHg, body temperature: 36.4 centigrade, computerised tomogram head: no stroke, C-reactive protein: 27, oxygen saturation: 88 %, oxygen saturation: 100 %, respiratory rate: 30-40 per minute, respiratory rate: 40 per minute, X-ray skeleton: no bone broken, troponin: 99 (units not specified), and Leucocyte count: 21 mol/l. Therapeutic measures were taken as a result of sepsis in form of naloxone and unspecified antibiotics. The patient died on 24Feb2021. An autopsy was not performed. The reporting physician stated that the sepsis was most probably unrelated to the vaccination. The reporter stated that the causal relationship between the suspect product and the sepsis was Unlikely, and the Pharmacovigilance Center has assessed the causal relationship between the suspect product and the general physical health deterioration and depressed mood as Possible. Case Summary and Reporter''s Comments: The undersigned has no real suspicion that the COVID vaccine was the cause of the patient''s death, but the report is submitted as the death occurred as consequence of a sepsis condition without known focus one week after the second dose (to be clarified). Sender''s Comments: causality assessment: Short-term malaise and fatigue are among the known side effects of the vaccine. A large proportion of those vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Sepsis is not among the known side effects of this vaccine. Data from use in frail patients with comorbidity is also limited, and such lack of information will be obtained in post-marketing studies. In the individual case, however, it is difficult to know whether the events are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination and the worsening of patient''s condition after vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Sepsis is considered a serious medical event, and although the cause is probably not related to vaccination, it is important that such events are also reported. Since the patient died, the report is classified as serious, although a causal link between the vaccine and sepsis and the death has not been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SEPSIS
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